Atovaquone and Proguanil Hydrochloride

Product NDC: 60760-498
11-digit product format: 607600498
Labeler code: 60760
Product ID: 60760-498_b699e059-0bf3-7a47-e053-2a95a90a2916
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atovaquone and Proguanil Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA091211
Marketing category: ANDA
Marketing start: 2011-08-18
Marketing end: 0000-00-00
Substance: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength: 250 mg/1; mg/1
Pharmacologic classes: Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60760-498		D	Discontinued by firm	2026-08-03
excluded package	package	60760-498	60760-498-04	D	Discontinued by firm	2026-08-03
excluded package	package	60760-498	60760-498-11	D	Discontinued by firm	2026-08-03
excluded package	package	60760-498	60760-498-13	D	Discontinued by firm	2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB		2011-01-12
A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB		2015-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091211-001	AB
A091211-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091211-001	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET / ORAL	AB	2011-01-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091211-002	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET / ORAL	AB	2015-04-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091211-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091211-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091211-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091211-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091211-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091211-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091211-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091211-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091211-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091211-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091211-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091211-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091211-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091211-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091211-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091211-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091211-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091211-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091211-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091211-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091211-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091211-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091211-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091211-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091211-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091211-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091211-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091211-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091211-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Bryant Ranch Prepack	e4ff57f7-07af-4872-ac3a-c521e098ccfe	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	BluePoint Laboratories	ad25ab65-42aa-48f6-b5ed-247f3685d5bf	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride Pediatric	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC	Glenmark Pharmaceuticals Inc.,USA	4b80d087-eaa7-448f-967e-344de7f16436	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211
Atovaquone and Proguanil Hydrochloride	ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	Proficient Rx LP	e74b00fc-8743-4e9d-8a83-aab8e531b3ba	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091211 application number: ANDA091211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-498-04	EA - Each	60760-498	7b395df3-809f-48b9-a91e-f86657f4796e	1	2017-03-06
60760-498-11	EA - Each	60760-498	7478a156-62c9-43ea-94f8-20f7268d627f	1	2017-03-06
60760-498-13	EA - Each	60760-498	a52b400e-4870-4dfe-8f24-63d2cabad427	1	2017-03-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y883P1Z2LT	ATOVAQUONE	95233-18-4	ATOVAQUONE
R71Y86M0WT	PROGUANIL HYDROCHLORIDE	637-32-1	PROGUANIL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-498-04	60760049804	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-498-04)	2016-08-01	0000-00-00	No	No	Current
60760-498-11	60760049811	11 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-498-11)	2016-08-01	0000-00-00	No	No	Current
60760-498-13	60760049813	13 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-498-13)	2016-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atovaquone and Proguanil Hydrochloride	St. Mary's Medical Park Pharmacy	2020-12-16	HUMAN PRESCRIPTION DRUG LABEL	6